Viral Specific T-cells for Treatment of COVID-19

NCT04406064 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2020-0353
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.

Conditions

Viral Infection

Outcome Measures

Primary Outcomes (1)

• Successful production of viral specific T-cells

  Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

  Within 30 days post culture initiation

Secondary Outcomes (1)

• Presence of viral-specific T-cells

  At 30 days after infusion

Study Arms (1)

Viral Specific T-cells (VSTs)

EXPERIMENTAL

Biological: Viral Specific T-cells (VSTs)

Interventions

Viral Specific T-cells (VSTs) BIOLOGICAL

VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.

Viral Specific T-cells (VSTs)

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have evidence of infection with SARS-CoV-2
• Patients with symptomatic COVID-19 disease, as defined by at least one of the following
• Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection
• Requirement for supplemental oxygenation
• Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation
• Age \>1 day
• Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
• Have failed at least one FDA-approved treatment for COVID-19 disease
• Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or sub-investigator either in person or by phone)

You may not qualify if:

• Uncontrolled bacterial or fungal infection
• Uncontrolled relapse of malignancy
• Unlikely to survive within 48 hours of VST infusion

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Hoxworth Blood Center: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Adam Nelson, MBBS, FRACP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)